Dentiq3D

System, Image Processing, Radiological

3D INDUSTRIAL IMAGING CO.,LTD.

The following data is part of a premarket notification filed by 3d Industrial Imaging Co.,ltd. with the FDA for Dentiq3d.

Pre-market Notification Details

Device IDK160666
510k NumberK160666
Device Name:Dentiq3D
ClassificationSystem, Image Processing, Radiological
Applicant 3D INDUSTRIAL IMAGING CO.,LTD. 413 Institute Of Computer Technology Seoul National University, Daehak-dong, Gwanak-gu,  KR
ContactJin Sa Kim
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 800 ROOSEVELT STE 110 Irvine,  CA  92620
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-09
Decision Date2016-10-05
Summary:summary

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